Adverse Event Reporting Timeline. All AEs should be reported immediately and • not later than 48 hours for events that represents a serious threat to public health; • not later than 10 days for events that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person; • not later than 30 days for events where a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person The clock for reporting starts as soon as any personnel of the medical device dealers, including sales representatives, is made aware of the AE. If there is uncertainty about whether the AE is reportable, dealers should still submit a report within the timeframe stipulated. Dealers should not unduly delay the reporting of AE(s) if information is incomplete. The initial report of an AE should contain as much relevant detail as is immediately available, but should not be delayed for the sake of gathering additional information. Dealers of medical devices are to follow up with a final report within 30 days of the initial reports, detailing the investigation into the AE. If the final report is not available within 30 days, a follow-up report is to be submitted. Follow-up reports may be requested as and when necessary.
